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  5. NDC Package Code: 64950-343-16 Hydrocodone Bitartrate And Acetaminophen

NDC Package 64950-343-16 Hydrocodone Bitartrate And Acetaminophen

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
64950-343-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
64950-343
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Substance Name:
Acetaminophen; Hydrocodone Bitartrate
Usage Information:
Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
11-Digit NDC Billing Format:
64950034316
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 856940 - HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution
  • RxCUI: 856940 - acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution
  • RxCUI: 856940 - acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution
  • RxCUI: 856940 - acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Genus Lifesciences Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/15mL
  • HYDROCODONE BITARTRATE 7.5 mg/15mL
    • Pharmacologic Class(es):
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040894
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-20-2020
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 64950-343-16?

    The NDC Packaged Code 64950-343-16 is assigned to a package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Genus Lifesciences Inc.. The product's dosage form is solution and is administered via oral form.

    Is NDC 64950-343 included in the NDC Directory?

    Yes, Hydrocodone Bitartrate And Acetaminophen with product code 64950-343 is active and included in the NDC Directory. The product was first marketed by Genus Lifesciences Inc. on November 20, 2020 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 64950-343-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 64950-343-16?

    The 11-digit format is 64950034316. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-264950-343-165-4-264950-0343-16